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| Tracking Information | |||||
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| First Received Date ICMJE | July 16, 2001 | ||||
| Last Updated Date | March 28, 2008 | ||||
| Start Date ICMJE | May 2001 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00021476 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Preventing Chronic Whiplash Pain | ||||
| Official Title ICMJE | Preventing Chronic Whiplash Pain: Biobehavioral Approach | ||||
| Brief Summary | This study is aimed at developing ways to prevent acute pain from becoming chronic pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury suggests that a person's initial emotional reactions, particularly fear of reinjury and subsequent avoidance of activity, contribute significantly to chronic pain and persistent disability. This study will treat people with WADs during the first three months after a motor vehicle accident with a behavioral and physical exercise program designed to encourage activity and discourage continued fear of movement, pain, and disability. The study will compare the effectiveness of two anxiety-reduction treatments to standard care in reducing pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle accidents. |
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| Detailed Description | More than 1.8 million people in the United States suffer from chronic pain and disability following motor vehicle accidents (MVAs) each year. The majority of these cases start with a relatively minor neck injury. The Quebec Task Force Study on Whiplash Associated Disorders (WAD) was created in 1989 to determine the clinical, public health, social, and financial determinants of WAD. Multiple studies have described the clinical features of WAD, which include neck, shoulder, arm, low back, and head pain; tinnitus; visual symptoms; dizziness; temporomandibular joint pain; and paraesthesias. Onset of these symptoms after the injury is usually delayed for several hours and worsens within 24 to 48 hours. Neck pain is the most frequent symptom, and between 14% and 42% of patients with WAD develop chronic neck pain symptoms. Studies suggest that the neck pain will either resolve in the first few months or persist indefinitely. One variable that may predict outcome after an MVA is the acute emotional response immediately after the MVA. A severe emotional reaction accompanied by neck pain and stiffness after an MVA could lead an injured person to avoid subsequent physical activity through such mechanisms as fear avoidance and fear of reinjury. Research investigating the evolution of chronic pain due to musculoskeletal injury suggests that initial emotional reactivity, particularly fear of reinjury and subsequent activity avoidance, contributes significantly to unremitting pain and persistent disability. Research based on this model has shown that early interventions targeting normalization of excessive emotionality and restriction of activities associated with fear following injury effectively prevent chronic pain due to back injury. No previous study has sought to intervene during the first three months after an MVA with a behavioral and physical exercise program to encourage activity and discourage continued fear of movement, pain and disability. This study consists of two primary components: (1) To compare the effectiveness of two anxiety-reduction treatments with standard care in reducing pain and activity limitations in patients with WADs 2 to 3 months following MVAs. (2) To test whether psychological responses to the initial trauma, such as fear avoidance, fear of injury, and negative affectivity, discriminate between symptomatic WAD patients and WAD sufferers whose symptoms had resolved 2 to 3 months post-MVA. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Safety Study | ||||
| Condition ICMJE | Whiplash Injuries | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | February 2007 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00021476 | ||||
| Responsible Party | Dennis C. Turk, Ph.D., University of Washington | ||||
| Study ID Numbers ICMJE | R01 AR47298, NIAMS-064 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | March 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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